The document discusses the fundamental standards of care that came into effect in April 2015 for all health and social care services in England. It outlines the 12 fundamental standards, including dignity and respect, safety, person-centered care, and duty of candour. It describes the Care Quality Commission's role in enforcing these standards through registration, inspection, and taking enforcement action when standards are breached. Breaches can result in prosecution, with fines depending on whether harm was caused. The standards aim to ensure care never falls below an acceptable standard as set out by the Francis inquiry into failings at Mid-Staffordshire hospital.

1. Fundamental standards
Elderly care conference 2015 – Andrew Peel

2. Fundamental standards
Andrew Peel, Browne Jacobson LLP

3. What are the fundamental
standards
•
•
standards below which care must never fall
came into force for all health and adult social care
from 1 April 2015
services
• form part of changes to the law recommended by Sir Robert
Francis following his inquiry into care at Mid Staffordshire
NHS Foundation Trust
Health and Social CareAct 2008 (RegulatedActivities)
Regulations 2014 (Part 3)
Care Quality Commission (Registration) Regulations 2009
(Part 4)
•
•

4. THE TWELVE FUNDAMENTAL STANDARDS
Dignity and respect Good governance
Consent Premises and equipment
Safety Fit and proper staff
Safeguarding from abuse Duty of candour
Food and drink Display of ratings
Person-centred care Complaints

5. CQC’s five key questions
• CQC ask five key questions about a service, is it
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safe?
effective?
caring?
responsive
well-led?
to people’s needs?

6. Legal footing for guidance
• CQC must take into account its guidance on
the regulations when
meeting
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–
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–
granting a registration
refusing an application for registration
cancelling or suspending a registration, or
varying, removing or imposing conditions on a registration
• impact of guidance
– CQC guidance on meeting the regulations is central to
 registration
 inspection and ratings
 enforcement

7. Breach without harm
• a breach of the following offences
prosecuted directly
may be
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–
Regulation 11- need for consent
Regulation 16(3) – receiving and acting on
complaints
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–
Regulation
Regulation
Regulation
17(3) – good governance
20(2)(a) – duty of candour
20A – requirement to display
performance assessments

8. Breach with avoidable harm
• to be able to prosecute for the following offences, the
breach must result in people who use services being
exposed to avoidable harm or significant risk of such
harm occurring or suffering a loss of money or property
as
–
–
a result of theft, misuse or misappropriation
Regulation
Regulation
treatment
Regulation
12
13
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–
safe care and treatment
Safeguarding from abuse and improper
– 14 – meeting nutritional and hydration needs

9. Regulation 11 – need for consent
• 11.—(1) care and treatment of service users must only
be provided with the consent of the relevant person
–
–
(2) paragraph (1) is subject to paragraphs (3) and (4)
(3) if the service user is 16 or over and is unable to give such consent
because they lack capacity to do so, the registered person must act in
accordance with the Mental Capacity Act 2005
(4) but if Part 4 or 4A of the Mental Health Act 1983 applies to a
service user, the registered person must act in accordance with the
provisions of that Act
(5) nothing in this regulation affects the operation of section 5 of the
Mental Capacity Act 2005, as read with section 6 of that Act (acts in
connection with care or treatment)
–
–

10. Sanction - consent
• CQC can prosecute for a breach of this regulation or
part of the regulation and can move directly to
prosecution without first serving a warning notice
criminal offence attracts maximum fine of £50,000
CQC can issue a fixed penalty notice of £4,000
additionally, CQC may also take other regulatory action
CQC must refuse registration if providers cannot satisfy
them that they can and will continue to comply with
this regulation
•
•
•
•

11. Regulation 16(3) – receiving and
acting on complaints
• 16.—(1) any complaint received must be investigated and
necessary and proportionate action must be taken in response to
any failure identified by the complaint or investigation
– (2) the registered person must establish and operate effectively an accessible
system for identifying, receiving, recording, handling and responding to complaints
by service users and other persons in relation to the carrying on of the regulated
activity
(3) the registered person must provide to the Commission, when requested to do so
and by no later than 28 days beginning on the day after receipt of the request, a
summary of
(a) complaints made under such complaints system
(b) responses made by the registered person to such complaints and any further
correspondence with the complainants in relation to such complaints, and
(c) any other relevant information in relation to such complaints as the Commission
may request
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–
–
–

12. Sanction - complaint
• failure to provide CQC, when requested to do so, a summary of
complaints, responses and any other relevant information they
seek is a criminal offence, directly prosecutable under the
Regulations, maximum fine £2,500
CQC can move directly to prosecution without first serving a
warning notice
CQC may also take other regulatory action
CQC must refuse registration if providers cannot satisfy them that
they can and will continue to comply with this regulation
•
•
•

13. Regulation 17(3) – good
governance
• 17.—(1) systems or processes must be established and operated
effectively to ensure compliance with the requirements in this Part
– 17(2): these systems must enable the registered person to
 assess, monitor and improve the quality and safety of the services provided
assess, monitor and mitigate the risks relating to the health, safety and welfare
of service users
maintain securely an accurate, complete and contemporaneous record in
respect of each service user, including a record of the care and treatment
provided to the service user and of decisions taken in relation to the care and
treatment provided
 maintain securely such other records as are necessary to be kept in relation to
employees and management of the regulated activity
17(3): provide report to CQC upon request regarding compliance of the above–

14. Sanction - governance
• CQC prosecution for a breach of part of regulation
(17(3)) if failure to provide written report upon request
(within 28 days of request)
–
–
criminal offence punishable by a fine of £2,500
CQC may prosecute without serving warning notice
 as failure may prevent provider from taking appropriate
timely action
regulatory action for other parts of regulation
CQC must refuse registration if not satisfied regulation can be
complied with
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–

15. Regulation
candour
20(2)(a) – duty of
• 20.— (1) registered persons must act in an open
and transparent way with relevant persons in
relation to care and treatment provided to service
users in carrying on a regulated activity

16. Duty of candour – what it means?
• providers should be open and transparent with
people who use services and those acting on their
behalf
regulation indicates specific requirements that
providers must follow when things go wrong with
care and treatment
•

17. Duty of candour
• what’s required
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–
–
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act in open and transparent way
soon as reasonably practicable
notifiable safety event
notify relevant person
provide reasonable support
• ‘notifiable safety event’
– incident where patient suffered (or could have suffered) unintended harm
that results in death, severe harm, moderate harm or prolonged
psychological harm
no inclusion of
 near miss
 no harm events
–

18. Duty of candour - guidance
• providers must promote a culture that encourages candour,
openness and honesty at all levels
– should be integral part of a culture of safety that supports
organisational and personal learning
• board level (or
transparency
providers must
of candour
providers must
equivalent) commitment to openness and
• tackle bullying and harassment in relation to duty
• investigate any instances where a member of staff
may have obstructed another in exercising their duty of candour

19. Duty of candour - sanction
• criminal offence – CQC can prosecute if failure to
–
–
notify verbally
comply with requirements
• CQC can move directly to prosecution without first serving
warning notice
additionally, CQC may also take other regulatory action
a
•
• on
–
–
conviction
potential fine of £2,500
adverse media interest
• defence to show took all reasonable steps and exercised all due
diligence to prevent the breach

20. Regulation 20A - requirement to
display assessments
• 20A.—(1) this regulation applies where, and to the extent that, a
service provider has received a rating of its performance by the
Commission following an assessment of its performance under
section 46(1) of the Act (reviews and performance assessments)
what this means… you must•
–
–
–
display your CQC rating in a place where a service user can see it
include this information on your website
make available to service user CQC’s latest report
• regulation applies to
– any CQC rating (outstanding, good, requires improvement or
inadequate) – the most recent rating should be displayed
all organisations including those rated before 1 April 2015–

21. Sanction – display assessment
•
•
level 2 fine - £500
CQC can prosecute for a breach of this regulation
or a breach of part of the regulation and can move
directly to prosecution without first serving a
warning notice. Additionally, CQC may also take
other regulatory action
CQC must refuse registration if providers cannot
satisfy us that they can and will continue to comply
with this regulation
•

22. Regulation
treatment
12 - safe care and
• 12.—(1) care and treatment must be provided in a safe way
service users
what it means…
for
•
– you must not give unsafe care or treatment or put a service user at
risk of harm that could be avoided
providers must assess the risks to a service user’s health and safety
during any care or treatment and make sure staff have the
qualifications, competence, skills and experience to keep them safe
–

23. Sanctions - safety
• CQC prosecution for breach of this regulation (or a breach of part
of
–
–
–
it) if failure
results in avoidable harm to a person using the service, or
a person using the service is exposed to significant risk of harm
criminal offence
 £50,000 fine, or
 fixed penalty notice and fine a service provider £4,000 and registered
manager £2,000
•
•
•
CQC
CQC
CQC
do not have to serve a warning notice before prosecution
may also take other regulatory action
must refuse registration if providers cannot satisfy us that
they can and will continue to comply with this regulation

24. Regulation 13 – safeguarding
from abuse
• 13.—(1) service users must be protected from abuse and improper treatment in
accordance with this regulation
(2) systems and processes must be established and operated effectively to prevent
and investigate allegations of abuse of service users
NB: a service user must not be deprived of their liberty for the purpose of receiving
care or treatment without lawful authority
safeguarding from abuse – what does it mean?
– service user must not suffer any form of abuse or improper treatment while receiving care
– this includes
 neglect
 degrading treatment
 unnecessary or disproportionate restraint
 inappropriate limits on freedom
NB: safeguarding must have the right level of scrutiny and oversight, with overall
responsibility held at board level or equivalent
•
•
•
•

25. Sanction - abuse
• CQC can prosecute for a breach of some parts of this regulation (13(1) to 13(4)) if a
failure to meet those parts
–
–
–
results in avoidable harm to a person using the service, or
a person using the service is exposed to significant risk of harm
£50,000 maximum fine
•
•
CQC does not have to serve a Warning Notice before prosecution.
alternatively, CQC may issue a fixed penalty notice and fine a service provider
£4,000 and registered manager £2,000
CQC may also take any other regulatory action
CQC must refuse registration if providers cannot confirm compliance with this
regulation
NB: DoL is not directly prosecutable offence (may give rise to claim for unlawful
detention)
•
•
•

26. Regulation 14 – meeting
nutritional and hydration needs
•
•
14.—(1) the nutritional and hydration needs of service users must be met
what does this mean?
– service user must have enough to eat and drink to keep them in good health
while you receive care and treatment
CQC will take into assessed needs / wishes i.e. specialist eating disorder
services / palliative care etc.
you must follow people’s consent wishes if they refuse nutrition and hydration,
unless:
 best interests decision under Mental Capacity Act 2005, or
 other forms of authority such as advance decisions
–
–

27. Sanction - nutrition
• CQC prosecution for a breach of regulation / part of the regulation
if a failure results in
–
–
–
–
avoidable harm to a person using the service
or a service user is exposed to significant risk of harm
£50,000 maximum fine
fixed penalty notice and fine of service provider (£4,000) and registered
manager (£2,000)
• CQC can move directly to prosecution without first serving a
warning notice
CQC may also take any other regulatory action
CQC must refuse registration if providers cannot confirm
compliance
•
•

28. Standards without prosecution
•
•
•
•
•
•
•
person centred care
dignity and respect
premises
staffing
fit and proper staff
fit and proper director
CQC cannot prosecute for a breach of these regulations but
–
–
can take regulatory action under its enforcement policy
must refuse registration if providers cannot satisfy CQC that they
and will continue to comply with this regulation
can

29. Regulation
care
9 – person-centred
• 9.—(1) the care and treatment of service users
must (a) be appropriate, (b) meet their needs,
and (c) reflect their preferences

30. Regulation 9 – what it means
Providers must
•
•
work in partnership with the service user
make any reasonable adjustments and provide
support to help them understand and make
informed decisions about their care and treatment
options, including the extent to which they may
wish to manage these options themselves
make sure that they take into account people’s
capacity and ability to consent
•

31. Regulation 9 – what it means
• either the service user, or a person lawfully acting on
their behalf, must be involved in the planning,
management and review of their care and treatment
provider must make sure that decisions are made by
those with the legal authority or responsibility to do
so, but within the requirements of the Mental
Capacity Act 2005, which includes the duty to consult
others such as carers, families and/or advocates
where appropriate
•

32. Regulation
respect
10 - dignity and
• 10.—(1) service users
respect
what does it mean?
must be treated with dignity and
•
– all staff must treat them with dignity and respect at all times. This
includes staff treating them in a caring and compassionate way
all communication with people using services must be respectful
(suitability of means; right to engage or not engage in
communication)
–
• NB: balance between autonomy / independence and
assessed needs (mitigate risks to support
independence)

33. Regulation 15
equipment
– premise and
• 15. —(1) all premises and equipment used by the service
must be
provider
–
–
–
–
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–
(a)
(b)
(c)
(d)
(e)
(f)
clean
secure
suitable for the purpose for which they are being used
properly used
properly maintained, and
appropriately located for the purpose for which they are being used
• what does it mean? Property and equipment must be
–
–
–
clean, suitable and looked after properly
secure and properly used
NB: includes personal safety ; personal property and money of service users;
surveillance must be in best interests of service user

34. Regulation 18 - staffing
• 18.—(1) sufficient numbers of suitably qualified,
competent, skilled and experienced persons must be
deployed in order to meet the requirements of this
Part
what is required?•
– a care provider must have enough suitably qualified,
competent and experienced staff to make sure they can
meet these standards
their staff must be given the support, training and
supervision they need to help them do their job
–

35. Staffing guidance
• providers must prevent / limit staff from obtaining
further qualifications appropriate to their role
providers must make sure that staff are able to meet
the requirements of the relevant professional regulator
throughout their employment (e.g. CPD)
support staff to join Accredited Voluntary Registers if
they wish
must not prevent or limit staff in meeting requirements
of professional regulators
•
•
•

36. Regulation 19
employees
– fit and proper
• 19.—(1) persons employed for the purposes of carrying
on a regulated activity must
–
–
(a)
(b)
be of good character
have the qualifications, competence, skills and
experience which are necessary for the work to be
performed by them, and
– (c) be able by reason of their health, after reasonable
adjustments are made, of properly performing tasks
which are intrinsic to the work for which they are
employed

37. Regulation
director
5 - fit and proper
• 5.—(1) this regulation applies where a service provider is a body
other than a partnership [or individual]
(2) unless the individual satisfies all the requirements set out in
paragraph (3), a service provider must not appoint or have in place
•
an
–
–
individual
(a)
(b)
the
as a director of the service provider, or
performing the functions of, or functions equivalent or similar to
functions of a director

38. Fit and proper
means
director – what it
• demands all board members
–
–
responsible for quality and safety of care
fit and proper to carry out role
• applies to all directors and
– governors of FT who sit on Trust Board as representatives of board
governors
senior managers
of
–
– for NHS bodies it applies to executive and non-executive, permanent,
interim and associate positions, irrespective of their voting rights
the requirement will also apply to equivalent director posts in other
providers
 e.g. trustees of charitable bodies and members of the governing bodies
unincorporated associations
–
of

39. Fit and proper person for
directors
• what’s required – section 5(3)
–
–
–
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good character (Schedule 4 Part 2)
physically and mentally fit
have necessary qualifications, skills and experience
not responsible, privy to, contributed or facilitated
serious misconduct or mismanagement whether
unlawful or not
absence of bankruptcy / barred (Schedule 4 Part 1)–

40. Action list
• keep full records
– appropriate recruitment process
• review service contracts
– update policies
• keep your nose clean
– CQC can
 bar a director
 refuse registration
 demand removal

41. Any questions?
Get in touch if you
questions or would
information.
have any
like further
t +(0)161 300 8030
e andrew.peel@brownejacobson.com